Therapy delivery system having an open architecture and a method thereof

ABSTRACT

A therapy delivery system having an open architecture and method of providing thereof are disclosed. The present invention provides a therapy dosage module having a control algorithm that can be replaced with a predefined or independently defined control algorithm. The tools necessary to create and test such control algorithms in the therapy dosage module in a simulated environment before implementing it in a live therapy system are also disclosed.

FIELD OF THE INVENTION

The present invention relates generally to chronic disease management,and more particularly, to a therapy delivery system having an openarchitecture via a replaceable control algorithm that regulates therapydelivery and a method thereof.

BACKGROUND OF THE INVENTION

Prior art therapy delivery systems typically implement one or morecontrol algorithms, which, in some instances, may be selected dependingon a particular need or condition of an individual receiving therapy. Insuch therapy delivery systems, each algorithm provides a number ofparameters which each may be populated with individualized data and/ortuned/customized within a given allowable range. However, with suchsystems, the logic of the algorithm in applying and using the parameterswith data has been formally tested to set the allowable range ofparameter values. Accordingly, the logic and ranges are unchangeable assuch changes are considered non-trivial as needing further testing tosee if acceptable. As algorithms are often developed from populationbased studies, in certain instances, such algorithms do not meet theparticular needs of an individual in managing a chronic disease, such asdiabetes.

SUMMARY OF THE INVENTION

It is against the above background that the present invention provides atherapy delivery system having an open architecture which in oneembodiment provides a replaceable control algorithm that regulatestherapy delivery and a method thereof. In other embodiments, the openarchitecture of the delivery system also enable parameter changes, suchas for example and not limited thereto, adding/removing parameters,modifying ranges, etc., and in still other embodiments, providing bothsuch algorithm and parameter changes. In further embodiments, thepresent invention permits such changes to be tested, evaluated andapprove for use in the therapy deliver system and/or device.

In accordance with one embodiment of the present invention, a therapydelivery system for an individual comprises a therapy dosage modulecomprising a first control algorithm replaceable with a second controlalgorithm customized to needs of the individual, the first and secondcontrol algorithms being defined to determine therapy for theindividual. The therapy delivery system also comprises a simulationmodule for providing a test environment simulating at least one or morephysiological conditions of the individual and enabling testing of thesecond control algorithm when implemented in the therapy dosage modulein the test environment before being used in the therapy delivery systemto deliver the therapy determined by the second control algorithm to theindividual.

In accordance with another embodiment of the present invention, atherapy delivery system for an individual comprises a metabolic sensorfor sensing a metabolic parameter of the individual and an input/outputinterface for exchanging therapy-related data with the individual. Inaddition, the therapy delivery system comprises a therapy dosage modulecomprising a first control algorithm replaceable with a second controlalgorithm, the first and second control algorithms being defined todetermine therapy for the individual, and a therapy delivery device fordelivering the therapy determined by the first or second controlalgorithm of the therapy dosage module. The second control algorithm iscustomized to needs of the individual prior to determination of thetherapy through testing of the second control algorithm in a testenvironment simulating at least one or more physiological conditions ofthe individual.

In accordance with another embodiment of the present invention, a methodof delivering therapy to an individual with an embodiment of a therapydelivery system comprises defining a control algorithm for determiningtherapy for the individual, the control algorithm customized to needs ofthe individual; providing a simulation module providing a testenvironment simulating at least one or more physiological conditions ofthe individual; implementing the control algorithm in the testenvironment; applying the control algorithm to a virtual patientpopulation in the test environment to identify any detrimental outcomesto patient health caused by the therapy determined by the controlalgorithm prior to usage of the control algorithm in the therapydelivery system to deliver the therapy to the individual; modifying thecontrol algorithm as necessary to substantially eliminate thedetrimental outcomes, if any, identified by the simulation module;implementing the control algorithm in the therapy delivery system; anddelivering therapy to the individual with the therapy delivery system,the therapy determined by the control algorithm.

BRIEF DESCRIPTION OF THE DRAWINGS

The following detailed description of the various embodiments of thepresent invention can be best understood when read in conjunction withthe following drawings, where like structure is indicated with likereference numerals and in which:

FIG. 1 is an illustration of a therapy delivery system according to oneembodiment of the present invention;

FIG. 2 is an illustration of a therapy delivery system according toanother embodiment of the present invention;

FIG. 3 is an illustration of a therapy delivery system according toanother embodiment of the present invention;

FIG. 4 is an illustration of a test system suite and a simulation moduleof a therapy delivery system according to one embodiment of the presentinvention; and

FIG. 5 is a process chart of a method delivering therapy to anindividual with a therapy delivery system according to one embodiment ofthe present invention.

The embodiments set forth in the drawings are illustrative in nature andare not intended to be limiting of the invention defined by the claims.Moreover, individual aspects of the drawings and the invention will bemore fully apparent and understood in view of the detailed description.

DETAILED DESCRIPTION

Referring initially to FIG. 1, a therapy delivery system 10 for anindividual generally comprises a therapy dosage module 11, a firstcontrol algorithm 16, a second control algorithm 18 that may replace thefirst control algorithm 16, one or more metabolic sensors 20A forsensing one or more metabolic parameters, a therapy delivery device 22,an input/output interface 24, and a communication module 26. Embodimentsof the therapy delivery system 10 of the present invention generally areconfigured to stabilize a metabolic parameter of an individual throughsensing the condition of the metabolic parameter, monitoringtherapy-related data, and delivering therapy necessary for stabilizationof the metabolic parameter as determined by a control algorithmfactoring the sensed metabolic parameter and the monitoredtherapy-related data.

For exemplary purposes only, according to one embodiment, the therapydelivery system 10 is an automated pancreas device comprising a glucosesensor as the metabolic sensor 20A, an insulin pump as the therapydelivery device 22, and an insulin dosing algorithm as the first orsecond control algorithm 16, 18. In the illustrative embodiment, theautomated pancreas device is configured to sense an individual's bloodglucose concentration in a continuous or pseudo-continuous manner and toadjust the infused insulin dosage more or less continuously based onsensed blood glucose concentration values, insulin infusion history,food intake, activity levels, and/or other therapy-related data (whethermonitored directly or inputted by the individual). The control algorithm16, 18 employed by the automated pancreas device to determineappropriate insulin dosages can take on various forms, ranging fromsimple rule sets to elaborate adaptive model-predictive controlalgorithms. As such, therapy delivered to the individual by the therapydelivery system 10 is insulin in a dosage amount, concentration,delivery rate, and/or delivery schedule determined by the first orsecond control algorithm 16, 18.

Further details of one suitable automatic pancreas device/system isdisclosed by commonly assigned and co-pending U.S. patent applicationSer. No. 12/119,143, entitled “SYSTEM FOR DEVELOPING PATIENT SPECIFICTHERAPIES BASED ON DYNAMIC MODELING OF PATIENT PHYSIOLOGY AND METHODTHEREOF,” which the entire disclosure thereof is herein fullyincorporated by reference. While the therapy delivery system 10 isexemplified as an automated pancreas device herein, it is contemplatedthat the therapy delivery system 10 may be embodied in, or applied to,various other chronic disease therapy management/support systems.

The therapy dosage module 11 of the therapy delivery system 10 comprisesan operating control system 12 and a failsafe module 14 having afail-safe algorithm. One suitable example of a fail-safemodule/algorithm is disclosed by commonly assigned and co-pending U.S.patent application Ser. No. 11/145,910, entitled “SYSTEM AND METHODPROVIDING FOR USER INTERVENTION IN A DIABETES CONTROL ARRANGEMENT,” andwhich the entire disclosure thereof is herein incorporated fully byreference. The operating system 12 may be configured to serve as acommunication hub between all of other components, hardware or software,of the therapy delivery system 10, and peripherals thereto. Suchcommunication may be transmitted to and from the operating controlsystem 12 via a wired connection or wirelessly. In addition, theoperating control system 12 may maintain time and calendar functions andsynchronize all operations of the therapy control system 10. Theoperating control system 12 may also comprise, or communicate with, adatabase for storing and/or retrieving data. Further, the operatingcontrol system 12 may perform unit conversion, data synchronization, andrecovery operations for the therapy delivery system 10.

The operating control system 12 is configured as having an openarchitecture platform that supports the operation of the therapydelivery system 10 while permitting the implementation and removal ofsoftware, including, but not limited to control algorithms, from theoperating control system 12 without interfering with the operationalfunctionality of the therapy delivery system 10. More particularly, thecontrol algorithms 16, 18 are general software utilities that provideoutputs, such as, but not limited to, recommended therapies, that arefunctions of time and inputs, such as, but not limited to, metabolicparameters and physiological conditions. Therefore, essentially, thecontrol algorithms 16, 18 determine therapies in response to varioustriggered events. The open architecture of the operating control system12 permits in one embodiment the replacement of one control algorithmwith another to enhance therapy determination specific to changing needsof the individual using the therapy delivery system 10. In addition, theopen architecture generally encapsulates a static part (i.e. theplatform) of the code of the operating control system 12, enablinggreater interaction between the therapy delivery system 10 and theindividual using it. In other embodiments, the operating control system12 permits parameter changes, such as for example and not limitedthereto, adding/removing parameters, modifying ranges, etc., and instill other embodiments, permits both such algorithm and parameterreplacement/changes.

Further, as mentioned above, in one embodiment the first controlalgorithm 16 is replaceable with the second control algorithm 18. Thismay be accomplished with the open architecture of the operating controlsystem 12 through a logical separation of the first and second controlalgorithms 16, 18 from hardware and software of the therapy deliverysystem 10. Thereby, the second control algorithm 18 replaces the firstcontrol algorithm 16 without interfering with the operationalfunctionality of the hardware and software of the therapy deliverysystem 10.

While the open architecture of the operating control system 12 of thetherapy dosage module 11 of the therapy delivery system 10 is describedherein as permitting the replacement/changing of control algorithms, itis contemplated that the open architecture may also permit theimplementation of one or more additional modular utilities 13 in theoperating control system 12 to enhance interaction between the therapydelivery system 10 and the individual using it. These modular utilities13, for example, may allow determination of inputs/outputs accessible tothe control algorithm in a form that assists with usability, entryefficiency, enhanced input detail, etc. For example, in one embodiment,a modular utility 13 may be an event module that stored data definingevent-specific parameters for activities and/or foods or other eventsoccurring in the individual's life style. In one embodiment, an eventmodule stores data for various physiological conditions of theindividual before, during, and/or after running for thirty minutes.

Generally, the second control algorithm 18 that replaces the firstcontrol algorithm 16 is customized to the needs of the individual usingthe device. It is contemplated, however, that both the first controlalgorithm 16 and the second control algorithm 18 may be customized tothe needs of the individual. Referring to FIG. 3, the second controlalgorithm 18 is customized through testing in a simulation module 36.This simulation module 36 provides a test environment simulating atleast one or more physiological conditions of the individual and enablestesting of the second control algorithm 18 when implemented in thetherapy dosage module 11 in the test environment. Thereby, the secondcontrol algorithm 18 is tested before being used in the therapy deliverysystem 10 to deliver therapy to the individual. It is furthercontemplated that both the first control algorithm 16 and the secondcontrol algorithm 18 may be customized to the needs of the individualprior to determination of the therapy through testing in the testenvironment.

The testing of the second control algorithm 18 in the simulation module36 comprises implementing the second control algorithm 18 in one or moretest systems 34 and applying the test systems 34 to a virtual patientpopulation of the test environment. As shown in FIG. 4, the simulationmodule 36 may be validated to substantially account for allphysiologically relevant test cases. Test cases, which generallycomprise target population analysis data, are incorporated into testenvironments provided by the simulation module 36 such that the virtualpatient population substantially accounts for all cases relevant to safeusage of the tested control algorithms and/or changes inparameters/parameter ranges. It is to be appreciated that test casesadditionally cover those test cases used to examine logical changes tothe algorithm, and/or use-cases not foreseen and/or specific to analgorithm on order to excite new logic.

FIG. 4 illustrates that, in addition to therapy-related data 25 specificto the individual, test cases covering a subspace relevant tophysiological conditions 42, not tested cases covering subspace relevantto physiological conditions 44, test cases covering subspace notrelevant to physiological conditions 46, and not tested cases coveringsubspace not relevant to physiological conditions 48 are incorporatedinto the test environments. The test cases 42, 44, 46, 48 should coverthe operating space to test all physiologically relevant cases. Rulesfor encompassing the operational range to ensure correct therapy for allrelevant cases within the operational space should also be provided. Forexample, as test cases 44 may impact the end user, care should be takento avoid missing critical cases, wherein rule can check for suchinstances, whereas test cases 46, 48 do not impact the end user and thuschecking may be unnecessary. The test cases 42, 46 and not tested cases44, 48 may be updated as necessary with new target population analysisdata and/or therapy-related regulation requirements. Further detailsconcerning test cases development, updating, and usage suitable for thepresent invention is disclosed by commonly assigned and co-pending U.S.patent application Ser. No. 12/119,201, entitled “MEDICAL DIAGNOSIS,THERAPY, AND PROGNOSIS SYSTEM FOR INVOKED EVENTS AND METHODS THEREOF,”which the entire disclosure thereof is herein fully incorporated byreference.

The testing of the second control algorithm 18 identifies anydetrimental outcomes to patient health caused by the therapy determinedby the second control algorithm 18 and any detrimental parameters of thesecond control algorithm 18 prior to usage in the therapy deliverysystem 10 to deliver therapy to the individual. The identifieddetrimental outcomes and/or parameters may be set forth in a test report40 generated by the simulation module 36. The second control algorithm18 may be modified as necessary to substantially eliminate thedetrimental outcomes, if any, identified by the simulation module 36. Ifmodified, the second control algorithm 18 may be undergo additionaltesting in the simulation module 36 to substantially ensure propermodification of the control algorithm 18. Thereafter, the second controlalgorithm 18 may be implemented with a therapy dosage module 11 in thetherapy delivery system 10, replacing the first control algorithm 16.While only the second control algorithm 18 is shown in FIG. 3 as beingtested in the simulation module 36, it is contemplated that the firstcontrol algorithm 16, or any other control algorithm that may beutilized by the therapy delivery system 10, may be tested before beingused in the therapy delivery system 10 to deliver therapy to theindividual and that the simulation module 36 may enable testing of boththe first and second control algorithms 16, 18 when implemented in thetest environment.

According to one embodiment of the therapy delivery system 10, shown inFIG. 2, the first control algorithm 16, the second control algorithm 18,or both, is selectable by the individual from a predefined list 32 ofcontrol algorithms customized to the needs of the individual. Thispredefined list 32 may include any number of such control algorithms sothat the individual or physician may replace a previously selectedcontrol algorithm with another so as to enhance therapy determinationfor the individual.

For example, FIG. 2 illustrates a predefined list 32 of individuallyselectable first, second, third, and fourth control algorithms 16, 18,28, 30 uniquely defined to determine therapy for the individual whenselected and implemented in the therapy dosage module 11 of the therapydelivery system 10. Further, the predefined list 32 of customizedcontrol algorithms can be uniquely defined from data such as, but notlimited to, analyses of target populations with which the individual maybe identified, modifications to the analyses of target populations,and/or changes in therapy-related regulation requirements. In addition,parameters of any or all of the control algorithms included in thepredefined list 32 may be modified for further customization to theneeds of the individual. For example, one or more parameters of thefirst control algorithm 16, one or more parameters of the second controlalgorithm 18, or both, are modifiable to further customize the firstcontrol algorithm 16, the second control algorithm 18, or both, to theneeds of the individual. The parameters/parameter ranges of the controlalgorithms may be used to define and/or formulate metabolic parameters,or other physiological conditions, of the individual or othertherapy-related data, such as for example, but not limited to, patientphysiology, meal information, carbohydrate intake, physical activity,and therapy infusion history. Generally, all such data is accessible tothe control algorithms 16, 18 in determining therapy for the individual.

Alternatively, according to another embodiment of the therapy deliverysystem 10, the first control algorithm 16, the second control algorithm18, or both, is defined independently and customized to the needs of theindividual. More particularly, the first control algorithm 16, thesecond control algorithm 18, or both, are defined by data specific tothe individual, rather than from analyses of target populations or othermore generalized information. Further, one or more parameters of theindependently defined first control algorithm, one or more parameters ofthe independently defined second control algorithm, or both, aremodifiable to further customize the independently defined first controlalgorithm, the independently defined second control algorithm, or both,to the needs of the individual.

By way of example only, independently defined control algorithms may bedefined by a physician who expresses to a manufacturer of suchalgorithms and/or therapy delivery systems an interest in using anindependently defined control algorithm. The manufacturer can assist thephysician in translating the intentions of the physicians into a controlalgorithm having a form conducive for implementation in an openarchitecture of an operating control system of a therapy dosage modulewhile acknowledging the constraints of a therapy delivery system. Thetranslation process and the resultant control algorithm may beunambiguously documented by the manufacturer to permit accurate andadequate evaluation of the control algorithm prior to usage indelivering therapy to an individual. Once defined, the control algorithmmay be tested in a simulation module, or other algorithm testing module,as described above to ensure compatibility with a therapy dosage moduleof a therapy delivery system and to identify possible detrimentalpatient outcomes and/or algorithm parameters. If desired, the simulationmodule may be verified under a standard validation protocol, asdescribed above with reference to FIG. 4. Once any necessarymodifications to the control algorithm are completed and usage of thecontrol algorithm is approved by the manufacturer and/or the physicianfollowing additional testing, the manufacturer may require the physicianto sign documentation, such as, but not necessarily limited to, arelease permitting the manufacturer to share all information related tothe translation, formulation, testing, and approval processes withrelevant regulatory agencies and a statement that the control algorithmand/or the therapy delivery system utilizing such algorithm are to beused only for clinical research under the responsibility of thephysician. Thereafter, the manufacturer may implement the controlalgorithm in the physician's therapy delivery system and inform therelevant regulatory agencies of the above-described processes andimplementation.

In another embodiment, the present invention is suitable for use withtest protocols that cover/identify the safe operation of an algorithm asa go/no go criteria. In such an embodiment, it is envisioned thatalgorithms which satisfy the test protocol should be acceptable fordirect deployment in field.

As mentioned above, the therapy dosage module 11 of the therapy deliverysystem 10 comprises an operating control system 12 and a failsafe module14. The failsafe module 14 defines one or more therapy limitationsindependent of the first and second control algorithms 16, 18 forsubstantially preventing delivery of therapy outside of the therapylimitations. These therapy limitations may be specific to the individualand define the limitations of permissible therapy that may be deliveredwhile avoiding substantial harm to the individual. Thereby, the failsafemodule 14 safeguards against the delivery of therapy in amounts,concentrations, rates, etc. that may result in detrimental outcomes inthe health of the individual. Should the failsafe module 14 prevent thedelivery of a therapy determined by the first or second controlalgorithm 16, 18, the failsafe module 14 may transmit a signal throughthe operating control system 12 to the input/output interface 24 tonotify the individual of the prevention of the therapy delivery and ofthe possible need for the individual to contact a physician and/ordirect the delivery of another therapy, whether predefined orindependently defined.

The input/output interface 24 of the therapy delivery system 10 isprovided for exchanging therapy-related data with the individual, suchas the notification of a prevention of a therapy delivery or thedirection to delivery a therapy, as mentioned above. More particularly,the input/output interface 24 receives data relating to physiologicalconditions, meals, and/or activities of the individual. Such data, forexample, may be sensed by the metabolic sensor 20A, directly inputted bythe individual, or transmitted by the communication module 26 fromanother electronic or digital source. In addition, the input/outputinterface 24 displays data relating to physiological conditions of theindividual, meals, recommended and/or delivered therapies, and/or a listof control algorithms approved for implementation in the therapy dosagemodule 11 of the therapy delivery system 10. As such, the input/outputinterface 24 generally is in communication, either wired or wireless, tothe failsafe module 14, the metabolic sensor 20A, the therapy deliverydevice, 22, and the communication module 26 through the operatingcontrol system 12 of the therapy dosage module 11.

The metabolic sensor 20A of the therapy delivery system 10 is providedfor sensing a metabolic parameter of the individual. A metabolicparameter may be, but is not limited to, blood glucose level, bloodpressure, or heart rate. In one embodiment, the metabolic sensor 20Asenses blood glucose levels, or other metabolic parameter, of theindividual on an intermittent basis. Alternatively, in anotherembodiment, the metabolic sensor 20A senses blood glucose levels, orother metabolic parameter, of the individual on a continual basis. Ineven yet another embodiment, the metabolic sensor 20A senses bloodglucose levels, or other metabolic parameter, of the individual whendirected by the individual or a physician through the input/outputinterface 24. Further, the therapy delivery system 10 may comprise oneor more metabolic sensors to sense one or more metabolic parameters. Forexample, as shown in FIG. 2, the therapy delivery system may comprisetwo metabolic sensors 20A, 20B for sensing metabolic A and metabolicparameter B with both sensors 20A, 20B in communication with theoperating control system 12 of the therapy dosage module 11. Moreparticularly, the metabolic sensors 20A, 20B sense metabolic parametersA and B and transmit signals indicative of the condition of thoseparameters to the operating control system 12. The operating controlsystem 12 may store these signals for a determined length of time forevaluation by the individual or a physician and/or for accessing by thecontrol algorithms 16, 18 in determining therapy.

The communication module 26 of the therapy delivery system 10 may beprovided for exchanging therapy-related data with a computer, portabledevice, network, or other related technology. For example, thecommunication module 26 may permit infrared transmission of data fromthe therapy delivery system 10 to a physician's computer so that thephysician may have access to and evaluate data pertaining to sensedmetabolic parameters, physiological conditions, and/or therapy deliveryhistory. Likewise, the communication module 26 may permit the individualor physician to transmit meal-specific data, such as carbohydratecontent, from a computer to the therapy delivery system 10 for storageand ready access by the individual when inputting through theinput/output interface 24 a proposed meal to enhance therapydetermination by the system 10.

The therapy delivery device 22 of the therapy delivery system 10 isprovided for delivering the therapy determined by the first or secondcontrol algorithm 16, 18 of the therapy dosage module 11. Generally, asshown in FIGS. 1 and 2, the therapy delivery device 22 receivesdirection from the operating control system 12 to provide therapy in anamount, in a concentration, at a delivery rate, and/or on a deliveryschedule, as determined by the first or second control algorithm 16, 18.

The delivery of therapy by the therapy delivery device 22 may also beaffected by the operational functionality of the therapy delivery system10. More particularly, the therapy delivery system 10 may operate in asemi-closed loop fashion or a fully closed loop fashion. Although thetherapy delivery device 22 generally is able to provide continuoustherapy delivery, such as continuous subcutaneous insulin infusion (CSIImode), the delivery device 22 can be used to emulate an intensivetherapy regimen of several therapies per day (MDI emulation mode). Assuch, an individual utilizing a therapy delivery system 10 operating inthe MDI emulation mode, or in a semi-closed loop fashion, generally mustapprove every therapy recommended by the control algorithm 16, 18 of thesystem 10 before the therapy is delivered to the individual by thetherapy delivery device 22. Use of a therapy delivery system 10operating in the MDI emulation mode may ease an individual's and/orphysician's transition from use of an established multiple therapydelivery regimen to an embodiment of the therapy delivery system 10.

An individual utilizing a therapy delivery system 10 operating in theCSII mode, or in a fully closed loop fashion, however, generallyreceives therapy delivery on an automated basis without prior approvalfrom the individual. This generally is due to the therapy deliverysystem 10 operating in the CSII mode frequently adjusting therapies forthe individual on a continuous, or substantially continuous, basis asthe individual's sensed metabolic parameters and/or other physiologicalconditions change. Since such adjustments in therapies may occur on arelatively high frequency, it is unlikely that the individual couldapprove every recommended therapy delivery. However, it is to beappreciated that high frequency is not the only reason. Adjustments intherapy may be also sporadic or sparse and in that case automation isuseful especially in cases where the delivery amount, which meet certainfailsafe guidelines, do not need user approval such as, for example,basal delivery cases. Therefore, the therapy delivery in one embodimentoccurs on an automated basis with such deliveries generally subject tothe failsafe module 14 and the defined therapy limitations describedabove.

The therapy delivery system 10 may also operate in a monitor only/nofeedback mode. In this mode, the system's 10 sensing and monitoringcapabilities, along with inputted data, may be completely ignored. Here,the therapy delivery system 10 is used as a continuous metabolicparameter sensor and a separate stand-alone therapy delivery device 22.The therapy delivery device 22 is controlled through an input/outputinterface 24 and trends in the metabolic parameter are sensed anddisplayed through the input/output interface 24 of the system 10. Inaddition, signals for notifying the individual of potential or oncomingdetrimental health outcomes, such as alarms for oncoming hypoglycemic orhyperglycemic conditions, are enabled. Also, sensed metabolic parametersand delivered therapies are stored by the operating control system 12 ofthe therapy delivery system 10. This monitor only/no feedback mode ofoperation may be used for purposes such as, but not limited to:optimizing an individual's therapy regimen; establishing therapydelivery programs for the therapy delivery device 22; using the therapydelivery system 10 to monitor the individual for a specified length oftime to determine an appropriate initial metabolic parameter settingbefore implementing one of the above-described operation modes of thetherapy delivery system 10 (i.e., MDI emulation mode and CSII mode); andproviding an individual and/or a physician with an opportunity tofamiliarize themselves with the therapy delivery system 10.

The therapy delivery system 10 may also permit various levels ofinteraction between the system 10 and an individual using it. Forexample, when the system 10 is utilized to continuously sense bloodglucose concentration, data inputted by the individual regarding pendingfood intake or exercise would be helpful for the a control algorithm 16,18 to maintain substantially stabilize blood glucose concentration.However, the willingness and/or ability of the individual to reliablyinput this data may vary from person-to-person. For example, a diabeticchild is less likely to be willing and/or able to reliably input suchdata than a motivated, highly compliant adult. Therefore, it should beunderstood that there generally exists a trade-off between theachievable level of control over a metabolic parameter, such as bloodglucose concentration, and the amount of interaction between the therapydelivery system 10 and the individual using it.

To further elaborate, two extreme cases are described. A first extremecase involves the use of a therapy delivery system 10 with no additionalinteraction between the system 10 and the individual. All insulin dosageadjustment decisions are based on the monitored blood glucoseconcentration and the previously delivered amounts of insulin and anygeneral knowledge that the system 10 has acquired about the individual'slife style. Without the additional interaction between the system 10 andthe individual using it, meals cannot be anticipated and counteractedbefore an increase in the glucose concentration occurs and is monitored.As such, control over blood glucose concentration will be limited andsomewhat sluggish.

A second extreme case involves the use of a therapy delivery system 10with extensive interaction between the system 10 and the individual.With extensive interaction, before each meal, the individual inputs anestimate of the amount of carbohydrate intake associated with theproposed meal along with a statement about the type of food that is tobe consumed with the meal. For example, a statement that the food is“light” may be understood by the system 10 that the food is easilydigestible, like fruit, while a statement of “heavy” may be understoodby the system 10 that the food is mixed with significant amounts ofprotein and/or fat. In addition, exercise is planned and inputted intothe therapy delivery system 10 well in advance. Also, the system 10 mayoutput a request to the individual at some time before the plannedexercise that the individual confirm that the exercise is still expectedto occur. The individual also inputs elevated stress levels, sickness,or other physiological conditions that may affect prospective insulininfusion. The input/output interface of the therapy delivery system 10and the operating control system 12 are designed to keep the interactionas intuitive, simple, and fast as possible. Since the system 10 knowsabout meals beforehand, it can react much more effectively to preventpost prandial hyperglycemic excursions. In addition, before a scheduledexercise period, the system 10 can appropriately reduce the insulininfusion to avoid strong glucose excursions into the hypoglycemicregion. The achievable overall level of control will be superior to thatof the system with less interaction with the individual.

In accordance with another embodiment, shown in FIG. 5, a method 50 ofdelivering therapy to an individual with an embodiment of a therapydelivery system is provided. The method generally comprises a controlalgorithm being defined for determining therapy for the individual,wherein the control algorithm is customized to the needs of theindividual in step 52. A simulation module in step 54 is provided forproviding a test environment simulating at least one or morephysiological conditions of the individual according to a simulationprotocol. The simulation protocol in one embodiment can cover a patientday to day activity such as meals with amount, composition, insulintherapy, medication, exercise. In other embodiments, the simulationprotocol may just cover certain combinations critical in understandingtherapy decision. In addition, the simulation protocol can be limited toshort duration such as few hours to long simulations covering few daysto many days to many months depending on use-case. The control algorithmmay then be implemented in a therapy dosage module in the testenvironment in step 56. The therapy dosage module and the controlalgorithm generally are then applied to a virtual patient population inthe test environment to identify any detrimental outcomes to patienthealth caused by the therapy determined by the control algorithm priorto usage of the control algorithm in the therapy delivery system todeliver the therapy to the individual in step 58. The control algorithmmay be modified as necessary to substantially eliminate the detrimentaloutcomes, if any, identified by the simulation module in step 60. Thetherapy dosage module and the control algorithm are then implementedwith the therapy delivery system in step 62. This permits the deliveringtherapy to the individual with the therapy delivery system, the therapydetermined by the control algorithm in step 64.

The method 50 may further comprise comparing the therapy determined bythe control algorithm with one or more therapy limitations independentlydefined by a failsafe module prior to delivery of the determined therapyto substantially prevent delivery of therapy outside of the definedtherapy limitations. The method 50 may also comprise replacing thecontrol algorithm in the therapy dosage module with a second controlalgorithm further customized to the needs of the individual.

While repeated reference is made herein to a first control algorithm anda second control algorithm, it is contemplated that any number ofcontrol algorithms may be defined, tested, implemented, and/or used withembodiments of the therapy delivery system of the present invention. Inaddition, any one control algorithm may be replaced with any othercontrol algorithm in accordance with the present invention.

It is noted that recitations herein of a component of the presentinvention being “configured” in a particular way or to embody aparticular property, or function in a particular manner, are structuralrecitations as opposed to recitations of intended use. Morespecifically, the references herein to the manner in which a componentis “configured” denotes an existing physical condition of the componentand, as such, is to be taken as a definite recitation of the structuralcharacteristics of the component.

It is noted that terms like “generally” and “typically,” when utilizedherein, are not utilized to limit the scope of the claimed invention orto imply that certain features are critical, essential, or evenimportant to the structure or function of the claimed invention. Rather,these terms are merely intended to identify particular aspects of anembodiment of the present invention or to emphasize alternative oradditional features that may or may not be utilized in a particularembodiment of the present invention.

For the purposes of describing and defining the present invention it isnoted that the terms “substantially” and “approximately” are utilizedherein to represent the inherent degree of uncertainty that may beattributed to any quantitative comparison, value, measurement, or otherrepresentation. The terms “substantially” and “approximately” are alsoutilized herein to represent the degree by which a quantitativerepresentation may vary from a stated reference without resulting in achange in the basic function of the subject matter at issue.

The foregoing description of the invention has been presented forpurposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise form disclosed, andother modifications and variations may be possible in light of the aboveteachings. The above embodiments disclosed were chosen and described toexplain the principles of the invention and its practical application tothereby enable others skilled in the art to best utilize the invention.It is intended that the appended claims be construed to include otheralternative embodiments of the invention except insofar as limited bythe prior art. Therefore, having described the invention in detail andby reference to specific embodiments thereof, it will be apparent thatmodifications and variations are possible without departing from thescope of the invention defined in the appended claims.

1. A therapy delivery system for an individual comprising: a therapydosage module comprising a first control algorithm replaceable with asecond control algorithm customized to needs of the individual, thefirst and second control algorithms being defined to determine therapyfor the individual; and a simulation module for providing a testenvironment simulating at least one or more physiological conditions ofthe individual and enabling testing of the second control algorithm whenimplemented in the therapy dosage module in the test environment beforebeing used in the therapy delivery system to deliver the therapydetermined by the second control algorithm to the individual.
 2. Thetherapy delivery system according to claim 1, wherein the second controlalgorithm replaces the first control algorithm without interfering withan operational functionality of hardware or software of the therapydelivery system.
 3. The therapy delivery system according to claim 1,wherein the first control algorithm, the second control algorithm, orboth, is selectable by the individual from a predefined list of controlalgorithms customized to the needs of the individual.
 4. The therapydelivery system according to claim 3, wherein one or more parameters ofthe first control algorithm, one or more parameters of the secondcontrol algorithm, or both, are modifiable to further customize thefirst control algorithm, the second control algorithm, or both, to theneeds of the individual.
 5. The therapy delivery system according toclaim 1, wherein the first control algorithm, the second controlalgorithm, or both, is defined independently and customized to the needsof the individual.
 6. The therapy delivery system according to claim 5,wherein one or more parameters of the independently defined firstcontrol algorithm, one or more parameters of the independently definedsecond control algorithm, or both, are modifiable to further customizethe independently defined first control algorithm, the independentlydefined second control algorithm, or both, to the needs of theindividual.
 7. The therapy delivery system according to claim 1,wherein: the testing of the second control algorithm in the simulationmodule comprises using the second control algorithm on a virtual patientpopulation of the test environment, and identifying any detrimentaloutcomes to patient health in the virtual patient population caused bythe therapy determined by the second control algorithm prior to usage inthe therapy delivery system to deliver therapy to the individual.
 8. Thetherapy delivery system according to claim 1, wherein the simulationmodule enables testing of both the first and second control algorithmswhen implemented in the therapy dosage module in the test environment.9. The therapy delivery system according to claim 1, wherein therapydelivered to the individual by the therapy delivery system is a dosageamount, concentration, delivery rate, specific time, and/or deliveryschedule of a drug determined by the first or second control algorithm.10. The therapy delivery system according to claim 1, wherein both thefirst control algorithm and the second control algorithm are customizedto the needs of the individual.
 11. The therapy delivery systemaccording to claim 1, wherein the therapy delivery system requires theindividual to approve therapy determined by the first or second controlalgorithm prior to delivery of the determined therapy.
 12. The therapydelivery system according to claim 1, wherein the therapy deliverysystem delivers therapy determined by the first or second controlalgorithm without requiring approval from the individual prior todelivery of the determined therapy.
 13. The therapy delivery systemaccording to claim 1, wherein the therapy delivery system furthercomprises an input/output interface for exchanging therapy-related datawith the individual.
 14. The therapy delivery system according to claim13, wherein the input/output interface receives data relating tophysiological conditions, meals, and/or activities of the individual,this received data being accessible to the first or second controlalgorithm in determining the therapy.
 15. The therapy delivery systemaccording to claim 13, wherein the input/output interface displays datarelating to physiological conditions of the individual, meals,recommended and/or delivered therapies, and/or a list of controlalgorithms approved for implementation in the therapy dosage module ofthe therapy delivery system.
 16. The therapy delivery system accordingto claim 1, wherein the therapy delivery system further comprises acommunication module for exchanging therapy-related data with acomputer, portable device, network, or other related technology.
 17. Thetherapy delivery system according to claim 1, wherein the therapydelivery system further comprises a failsafe module defining one or moretherapy limitations independent of the first and second controlalgorithms for substantially preventing delivery of therapy outside ofthe therapy limitations.
 18. The therapy delivery system according toclaim 1, wherein the therapy delivery system further comprises one ormore metabolic sensors for sensing one or more metabolic parameters ofthe individual.
 19. The therapy delivery system according to claim 1,wherein the therapy delivery system further comprises one or moretherapy delivery devices for delivering therapy determined by the firstor second control algorithm of the therapy dosage module.
 20. A therapydelivery system for an individual comprising: a metabolic sensor forsensing a metabolic parameter of the individual; an input/outputinterface for exchanging therapy-related data with the individual; atherapy dosage module comprising a first control algorithm replaceablewith a second control algorithm, the first and second control algorithmsbeing defined to determine therapy for the individual; and a therapydelivery device for delivering the therapy determined by the first orsecond control algorithm of the therapy dosage module, wherein thesecond control algorithm is customized to needs of the individual priorto determination of the therapy through testing of the second controlalgorithm in a test environment simulating at least one or morephysiological conditions of the individual.
 21. The therapy deliverysystem according to claim 20, wherein both the first control algorithmand the second control algorithm are customized to the needs of theindividual prior to determination of the therapy through testing in thetest environment.
 22. The therapy delivery system according to claim 20,wherein the metabolic sensor senses blood glucose levels of theindividual on an intermittent basis.
 23. The therapy delivery systemaccording to claim 20, wherein the metabolic sensor senses blood glucoselevels of the individual on a continual basis.
 24. A method ofdelivering therapy to an individual with a therapy delivery system, themethod comprising: defining a control algorithm for determining therapyfor the individual, the control algorithm customized to needs of theindividual; providing a simulation module providing a test environmentsimulating at least one or more physiological conditions of theindividual; implementing the control algorithm in the test environment;applying the control algorithm to a virtual patient population in thetest environment to identify any detrimental outcomes to patient healthcaused by the therapy determined by the control algorithm prior to usageof the control algorithm in the therapy delivery system to delivertherapy to the individual; modifying the control algorithm as necessaryto substantially eliminate the detrimental outcomes, if any, identifiedby the simulation module; implementing the control algorithm in thetherapy delivery system; and delivering therapy to the individual withthe therapy delivery system, the therapy determined by the controlalgorithm.
 25. The therapy delivery system according to claim 24,wherein the method further comprises comparing the therapy determined bythe control algorithm with one or more therapy limitations independentlydefined by a failsafe module prior to delivery of the determined therapyto substantially prevent delivery of therapy outside of the definedtherapy limitations.
 26. The therapy delivery system according to claim24, wherein the method further comprises replacing the control algorithmin the therapy dosage module with a second control algorithm furthercustomized to the needs of the individual.